The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

FDA's quality system regulation (QSR) details specific activities that mustoccur for a new medical device to be made and commercialized in theUnited States. QSR ...

A new draft guidance document published by the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH) illustrates a voluntary process by which companies can qualify ...

The FDA released updated guidance on May 29, 2026, formalizing expectations for human factors information in medical device ...

Learn best practices and proven strategies to address challenges presented by today’s shifting regulatory environment and the keys to commercial success. This is an On-demand recording from July 2020.

Electronics and Telecommunications Research Institute (ETRI) of Korea and its research team have successfully developed core material and device process technologies of gallium oxide (Ga2O3) power ...

Major processes in semiconductor wafer fabrication: 1) wafer preparation, 2) pattern transfer, 3) doping, 4) deposition, 5) etching, and 6) packaging. The process of creating semiconductors can be ...

Silvaco Group, Inc., a provider of TCAD and EDA software, has announced that Excelliance MOS has adopted its Design Technology Co-Optimization (DTCO) flow, incorporating Victory TCAD and UTMOST IV ...

Eclypsium security researchers have uncovered UEFI vulnerabilities in the Illumina iSeq 100 DNA sequencer, but the broader issue involves the device development process at large. In highlighting ...

(RTTNews) - 908 Devices (MASS) announced that GlaxoSmithKline (GSK) has purchased an additional REBEL cell culture media analyzer. GSK will now have a total of five REBEL analyzers being used by its ...